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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Piperacillin-Tazobactam

Last Update: October 20, 2020.

OVERVIEW

Introduction

Piperacillin is parenterally administered, extended-spectrum ureidopenicillin which, when combined with the beta-lactamase inhibitor tazobactam, is used to treat moderate-to-severe infectious due to susceptible organisms including lactamase producing penicillin-resistant bacteria. Piperacillin-tazobactam has been linked with idiosyncratic liver injury, including cases of DRESS and cholestatic liver injury that can be prolonged and even fatal.

Background

Piperacillin-tazobactam is the combination of a fourth generation, extended-spectrum penicillin and a beta-lactamase inhibitor that is used for moderate-to-severe infections caused by susceptible agents, such as (but not limited to) Escherichia coli, many Bacteroides and Klebsiella species, Staphylococcus aureus, and Hemophilus influenzae. The combination of piperacillin with tazobactam provides broad activity against beta-lactamase producing penicillin-resistant bacterial species. This combination was approved for use in the United States in 1985 and is generally reserved for severe infections requiring parenteral therapy. Piperacillin-tazobactam is available in parenteral form for intravenous use in generic forms and under the trade name Zosyn. Recommended doses are 3 to 4.5 grams of piperacillin with 0.375 to 0.5 grams of tazobactam every 6 to 8 hours for 7 to 14 days. Common side effects include headache, dizziness, nausea, diarrhea, constipation, skin rash and hypersensitivity reactions. Rare but potentially severe adverse events include anaphylactic and hypersensitivity reactions, Stevens Johnson syndrome and toxic epidermal necrolysis.

Hepatotoxicity

In large clinical trials, ALT elevations were reported in 6% to 15% and bilirubin elevations in 3% to 5% of patients receiving piperacillin-tazobactam, with considerably lower rates in patients receiving comparator antibiotics (such as imipenim-cilastatin) and lower rates reported with piperacillin alone. These abnormalities were reported to resolve quickly with stopping therapy. Rare instances of idiosyncratic liver injury have been reported in persons receiving the piperacillin without tazobactam and a similar pattern of injury has been reported with the combination. The injury is typically cholestatic or mixed and arises 1 to 3 weeks after starting and often days or weeks after stopping the antibiotic. The liver injury is usually self-limited but severe cases of cholestatic hepatitis can lead to prolonged jaundice or persistence of minor alkaline phosphatase elevations for 6 to 12 months after clinical resolution. Immunoallergic features may be present but are generally mild.

In addition, the combination of piperacillin and tazobactam has been implicated in more than a dozen cases of drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, usually arising after 2 to 3 weeks of long term therapy initially with rash and fever followed by liver or renal dysfunction or both. The liver injury is usually mixed or cholestatic but hepatocellular instances have also been reported. In many cases the liver injury is mild and overshadowed by the systemic symptoms and rash. Piperacillin-tazobactam has also been linked to instances of Stevens Johnson syndrome, although in most cases, other drugs known to be associated with the syndrome were being taken. These forms of hypersensitivity with liver involvement have not been reported with piperacillin alone. Because piperacillin-tazobactam is used for serious infections, patients are often taking multiple medications including other antibiotics such as vancomycin, azithromycin or ciprofloxacin, making the causality assessment challenging.

Likelihood score: B (likely rare cause of clinically apparent liver injury).

Mechanism of Injury

The cause of the liver injury associated with piperacillin use is probably hypersensitivity or allergy. Cases of reoccurrence on reexposure have been reported. The role of tazobactam in the injury is uncertain, but it appears to be important in cases of DRESS syndrome.

Outcome and Management

In the few cases of delayed cholestatic hepatitis that have been described with piperacillin with or without tazobactam, patients have recovered within a few weeks of stopping. Cases with DRESS syndrome tend to be more prolonged and are usually treated with corticosteroids for the manifestations of fever and rash. Whether corticosteroids also improve the liver and renal involvement is not clear, but they are generally continued for at least 6 to 8 weeks. Rechallenge is usually followed by recurrence of injury which can be more severe. Patients with piperacillin induced hepatitis should avoid reexposure and should take other penicillins and cephalosporins with caution.

Drug Class: Antiinfective Agents, Penicillins (Fourth Generation)

Other Drugs in the Class: Piperacillin, Ticarcillin, Ticarcillin-Clavulanate

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Piperacillin-Tazobactam – Generic, Zosyn®

DRUG CLASS

Antiinfective Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULAS AND STRUCTURES

DRUGCAS REGISTRY NOMOLECULAR FORMULASTRUCTURE
Piperacillin-Tazobactam157044-21-8C23-H27-N5-O7-S.
C10-H12-N4-O5-S.Na
image 135079097 in the ncbi pubchem database

ANNOTATED BIBLIOGRAPHY

References updated: 20 October 2020

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    (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, 323 [36%] were attributed to antibiotics of which 106 [12%] were due to penicillins including one to a 1st, three to a 2nd [all due to oxacillin], 97 to a 3rd [91 to amoxicillin-clavulanate, and 6 to amoxicillin alone] and five to a 4th generation penicillin [all 5 to piperacillin-tazobactam]).
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    (In a genome wide association study of 387 patients with immediate allergic reactions to beta-lactam antibiotics, several class 2 HLA associations [HLA-DRA regions] were found for penicillin responses).
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    (Review of the most common causes of drug induced liver injury based upon categorization from LiverTox, amoxicillin-clavulanate but not other forms of penicillin were in the top category of causes of liver injury [likelihood scores of A, with more than 100 cases published in the literature]).
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    (Demonstration of T cell priming to drugs linked with specific class I HLA-alleles).
  • Nicoletti P, Aithal GP, Björnsson ES, Andrade RJ, Sawle A, Arrese M, Barnhart HX, et al. International Drug-Induced Liver Injury Consortium, Drug-Induced Liver Injury Network Investigators, and International Serious Adverse Events Consortium. Association of liver injury from specific drugs, or groups of drugs, with polymorphisms in HLA and other genes in a genome-wide association study. Gastroenterology. 2017;152:1078–89. [PMC free article: PMC5367948] [PubMed: 28043905]
    (A genome wide association study done on 862 Caucasian patients with drug induced liver injury demonstrated a strong link with HLA-A*33:01 in those with cholestatic liver injury, particularly in cases attributed to terbinafine, fenofibrate and ticlopidine).
  • Cabañas R, Calderon O, Ramirez E, Fiandor A, Prior N, Caballero T, Herránz P, et al. Piperacillin-induced DRESS: distinguishing features observed in a clinical and allergy study of 8 patients. J Investig Allergol Clin Immunol. 2014;24:425–30. [PubMed: 25668894]
    (Eight patients with DRESS syndrome attributed to piperacillin-tazobactam were identified at a single Spanish referral center in Madrid between 2006 and 2012; 3 women, 5 men, ages 39 to 83 years, all with rash and eosinophilia, 6 with liver involvement [mixed or cholestatic injury] but none with jaundice, 3 with renal involvement, all survived).
  • Blumenthal KG, Youngster I, Rabideau DJ, Parker RA, Manning KS, Walensky RP, Nelson SB. Peripheral blood eosinophilia and hypersensitivity reactions among patients receiving outpatient parenteral antibiotics. J Allergy Clin Immunol. 2015;136:1288–94.e1. [PMC free article: PMC4640981] [PubMed: 25981739]
    (Among 824 patients who underwent outpatient parenteral antibiotic therapy for at least 2 weeks, 210 [25%] developed eosinophilia including 58 of 207 [28%] who received “penicillins” of whom 3 developed signs of “possible” DRESS syndrome; specific penicillins accounting for the cases were not provided).
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    (Review of mechanisms of idiosyncratic drug induced liver injury focusing upon chemically reactive drug metabolites and genetic associations, particularly those with HLA alleles that implicate the adaptive immune response).
  • Kraleti S, Khatri N, Jarrett D. Piperacillin-tazobactam induced interstitial nephritis, hepatitis and serum sickness-Like Illness. J Ark Med Soc. 2016;112:278–80. [PubMed: 27434982]
    (30 year old woman developed fever and rash during intravenous therapy with vancomycin and piperacillin-tazobactam with accompanying liver and kidney disfunction and leukocytosis [bilirubin 2.3 mg/dL, ALT 180 U/L, Alk P 708 U/L, INR 2.5, creatinine 5.4], responding rapidly to stopping therapy and treatment with corticosteroids).
  • Patel J, Walayat S, Kalva N, Palmer-Hill S, Dhillon S. Bile cast nephropathy: a case report and review of the literature. World J Gastroenterol. 2016;22:6328–34. [PMC free article: PMC4945990] [PubMed: 27468221]
    (54 year old man developed jaundice 2 weeks after starting intravenous piperacillin-tazobactam for osteomyelitis with progressive jaundice and renal dysfunction [bilirubin 19.3 rising to 29.0 mg/dL, ALT 129 U/L, Alk P 851 U/L, INR 1.4, creatinine 2.1 rising to 5.5 mg/dL], treated with dialysis and ursodiol but after six months of progressive disease underwent successful, combined renal and liver transplant).
  • Cirulli ET, Nicoletti P, Abramson K, Andrade RJ, Björnsson ES, Chalasani N, Fontana RJ, et al. Drug-Induced Liver Injury Network (DILIN) investigators. International DILI consortium (iDILIC). A missense variant in PTPN22 is a risk factor for drug-induced liver injury. Gastroenterology. 2019;156:1707–16.e2. [PMC free article: PMC6511989] [PubMed: 30664875]
    (Genome wide association studies on 2048 patients with drug induced liver injury and 12,439 controls identified a variant in PTPN22 which was highly associated with liver injury, allele frequency being 0.12 among cases and 0.08 among controls with highest association in Northern Europeans and in cases of amoxicillin-clavulanate, PTPN22 being a cellular kinase involved in modulation of immune reactions).

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